Like previous versions of ISO / TS 16949 which incorporated ISO 9001, IATF 16949 includes the requirements of ISO 9001:2015.
There are numerous changes / additions in IATF 16949, over and above those in ISO 9001:2015. Refer ISO 9001:2015 Transition.
The Quality Management System needs to follow the process-approach, therefore the IATF16949 -specific requirements can be slotted under the appropriate processes.
Similar to ISO 9001:2015, IATF 16949:2016 does not have requirements for “documented procedures”, instead there are requirements for “documented processes” for certain of the requirements, which allow organisations more flexibility in deciding on the format for an effective “documented process”.
The risks and opportunities arising from the context of the organisation and the relevant requirements of interested external and internal parties would include:
The issues arising from the context etc. may mean that the abovementioned documentation would need to be updated. ISO 9001:2015 requires that the determination of risks / opportunities must take into consideration the context of the organisation, and the relevant requirements of interested parties, so this relationship must be demonstrated.
Application of this requirement is much broader that previous, for example all products and processes, including those that are outsourced, shall conform to all applicable statutory and regulatory requirements